Pfizer Wins Ruling to Block Generic Lyrica Until 2018

Pfizer Inc., the world’s biggest drugmaker, won a court ruling that will block generic versions of its No. 1 product, Lyrica, in the U.S. until December 2018.

Teva Pharmaceutical Industries Ltd., Actavis Plc and Lupin Ltd. are among the generic-drug makers that would infringe a valid patent on the pain medicine, the U.S. Court of Appeals for the Federal Circuit in Washington said in an opinion today on its website. The other generic-drug makers in the case were Sun Pharmaceutical Industries Ltd., Wockhardt Ltd. and Mylan Inc.

Lyrica has become increasingly important to Pfizer’s earnings since the New York-based company lost patent protection on its cholesterol pill Lipitor, which once generated almost $13 billion a year. Sales of Lyrica, used to treat shingles, fibromyalgia, epilepsy, and hot flashes, reached $4.6 billion last year, accounting for 9 percent of Pfizer’s total revenue.

The appeal centered on a single aspect of a patent covering the active ingredient, pregabalin. The generic-drug makers argued that the patent didn’t adequately describe a new invention, and was an obvious variation of other compounds. They conceded that, if the patent claim was upheld, they had no chance at winning on that or a second patent.

“We perceive no error in the district court’s construction” of what the patent claim covers, the three-judge panel wrote.

The case is Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 12-1576, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 09cv307, U.S. District Court for the District of Delaware (Wilmington).

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